MAUDE Adverse Event Report: LUMENIS LTD SLIMLINE SIS EZ; POWERED LASER SURGICAL INSTRUMENT

Model Number	0644-019-01
Medical Device Problem Codes	Break (1069); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/27/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a transurethral lithotomy procedure to treat kidney stones, the fiber tip broke off and it remained inside the renal pelvis of the patient.It was tried to used forceps for foreign objects in order to remove the fiber, but it did not work.The case was finished with the fiber piece remaining inside the patient; however, the intended treatment was not completed.It was informed that about 2 cm of the fiber jacket had been stripped and it is unknown how many times the reusable fiber was used.Another surgery will be performed at a later date, and the fiber is being asked to be retrieved for examination.Additionally, it was informed that the broken fiber tip was about 5 mm.The renal stone remained inside the body of the patient, and it was not completely removed, therefore, the patient was sent to another hospital.As of today, the patient is stable in the hospital and the plan is to perform a transurethral lithotomy procedure.There is no information of the date for the next surgery.
Additional Manufacturer Narrative
Upon receipt of this fiber at our quality assurance laboratory, this device was thoroughly analyzed.Visual analysis identified that the fiber tip was broken and exhibiting some defect on the connector face.It is probable that procedural elements like physician technique, size and composition of the material being ablated could contributed with the fiber tip break, thus, confirming the reported event.It is possible that the damaged observed on the connector face could have occurred during use of the fiber.Review of the history record (dhr) showed the fiber met all manufacturing specifications prior to release.According to the device instructions for use informs the user to: inspect the fiber for kinks, punctures, fractures, or other damage.If the fiber appears damaged, do not use the fiber, return it to the supplier for replacement.
Event or Problem Description
It was reported that during a transurethral lithotomy procedure to treat kidney stones, the fiber tip broke off and it remained inside the renal pelvis of the patient.It was tried to used forceps for foreign objects in order to remove the fiber, but it did not work.The case was finished with the fiber piece remaining inside the patient; however, the intended treatment was not completed.It was informed that about 2 cm of the fiber jacket had been stripped and it is unknown how many times the reusable fiber was used.Another surgery will be performed at a later date, and the fiber is being asked to be retrieved for examination.Additionally, it was informed that the broken fiber tip was about 5 mm.The renal stone remained inside the body of the patient, and it was not completely removed, therefore, the patient was sent to another hospital.As of today, the patient is stable in the hospital and the plan is to perform a transurethral lithotomy procedure.There is no information of the date for the next surgery.

• Brand Name: SLIMLINE SIS EZ
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): LUMENIS LTD; hakidma 6; yokneam 20692 04; IS 2069204
• Manufacturer (Section G): MOLEX LLC; 18019 n 25th ave; phoenix AZ 85023
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 19868710
• Report Number: 2124215-2024-44394
• Device Sequence Number: 7666161
• Product Code: GEX
• UDI-Device Identifier: 07290109145587
• UDI-Public: 07290109145587
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K170121
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 0644-019-01
• Device Catalogue Number: 0644-019-01
• Device Lot Number: 0015040423
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/02/2024
• Supplement Date Received by Manufacturer: 09/24/2024
• Initial Report FDA Received Date: 07/30/2024
• Supplement Report FDA Received Date: 10/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/05/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown